Regulatory Affairs Consultant – CMC Plasma Products

This is a fully remote position, open to applicants in United Kingdom, +6 more countries.

📋 Description

• Formulate strategies and plans for submissions related to post-approval CMC activities, including variations, renewals, market expansions, and annual reports.

• Evaluate change controls and deliver regulatory assessments regarding quality changes in production and quality control.

• Examine study reports from quality control and production departments to ensure compliance with regulatory standards.

• Oversee the preparation of submissions in collaboration with manufacturing, supply chain, quality control, quality assurance, regulatory departments, and local companies.

• Draft and/or review submission materials associated with variations and inquiries from health authorities.

• Manage projects utilizing Regulatory Information Management systems and oversee global submissions.

• Recognize, escalate, and address risks tied to regulatory procedures and activities.

⛳️ Requirements

• University-level education, ideally in Life Sciences, or equivalent experience.

• Prior experience in regulatory affairs, particularly in technical/CMC/quality within the pharmaceutical sector.

• Strong knowledge of CMC and post-approval regulatory obligations.

• Experience in drafting CMC (technical) sections of regulatory documents such as registration files or variations.

• Must possess knowledge of plasma product processes.

• Background in validation, Quality Assurance, or production in the pharmaceutical field, including experience in preparing regulatory documentation.

• Understanding of qualification/validation principles.

• Proficient in Word, PowerPoint, and Excel.

• Fluent in English, both written and spoken.

• Familiarity with Veeva Vault is an asset.

🏝️ Benefits

• Options for home or office-based work.

• Full-time employment.